Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Massive study tracks IBD drug safety in kids for years

NCT ID NCT00606346

Knowledge-focused Sponsor: Janssen Biotech, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study follows nearly 5,000 children with Crohn's disease, ulcerative colitis, or indeterminate colitis to monitor the long-term safety of their treatments, including the drug infliximab. Researchers collect information on side effects, disease activity, and quality of life over time. The goal is to better understand how these therapies affect children in the real world.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

4,970 people

The number who actually took part.

Started

May 2007

Expected to finish

Jun 2038

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This is a registry of pediatric patients with IBD (e.g., CD, UC, or IC in C0168Z02 and CD in REMICADEPIB4002 and REMICADEPIB4003) who were treated with infliximab and/or other medical therapies for IBD. Information will be collected on patient demographics, disease characteristics, clinical status, quality of life, medications, and dose and frequency of administration of infliximab, other biologics, and immune modulators.

Ages

1 month to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: C0168Z02 - Confirmed diagnosis of Crohn's disease, Ulcerative Colitis, or Indeterminate Colitis for at least 2 months The parent/legal guardian must be capable of providing written informed consent, and assent should be obtained from the child according to local regulations (age at which assent is given may vary by the IRB or EC). The patient's physician expects the patient to be scheduled for a medical encounter (and/or other direct contact) at least every 6 months, as part of their usual care, at the time of enrollment. REMICADEPIB4002 and REMICADEPIB4003: Confirmed diagnosis of Crohn's disease or Ulcerative Colitis for at least 2 months Exclusion Criteria: C0168Z02: 17 years of age or older, with the exception of patients who participated in the Sponsor's conducted pediatric IBD clinical trials. Have other Crohn's-like diseases that are associated with genetic diseases (eg, glycogen storage disease). The patient and parent/guardian are not able to adhere to the protocol requirements. Are participating in any clinical trial for an investigational agent that is not commercially available. REMICADEPIB4002 and REMICADEPIB4003: Less than 6 years of age or 17 years of age or older.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Crohn's disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Crohn disease indeterminate colitis inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease Indeterminate colitis Inflammatory bowel diseases Ulcerative colitis

Contacts and locations

Locations

  • Study site

    Mobile, Alabama, United States

  • Study site

    Phoenix, Arizona, United States

  • Study site

    Los Angeles, California, United States

  • Study site

    Oakland, California, United States

  • Study site

    Sacramento, California, United States

  • Study site

    San Diego, California, United States

  • Study site

    San Francisco, California, United States

  • Study site

    Aurora, Colorado, United States

  • Study site

    Hartford, Connecticut, United States

  • Study site

    New Haven, Connecticut, United States

  • Study site

    Gainesville, Florida, United States

  • Study site

    Miami, Florida, United States

  • Study site

    Orlando, Florida, United States

  • Study site

    Atlanta, Georgia, United States

  • Study site

    Boise, Idaho, United States

  • Study site

    Chicago, Illinois, United States

  • Study site

    Lexington, Kentucky, United States

  • Study site

    New Orleans, Louisiana, United States

  • Study site

    Portland, Maine, United States

  • Study site

    Boston, Massachusetts, United States

  • Study site

    Newton, Massachusetts, United States

  • Study site

    Worcester, Massachusetts, United States

  • Study site

    Detroit, Michigan, United States

  • Study site

    Southfield, Michigan, United States

  • Study site

    Minneapolis, Minnesota, United States

  • Study site

    Rochester, Minnesota, United States

  • Study site

    Boys Town, Nebraska, United States

  • Study site

    Las Vegas, Nevada, United States

  • Study site

    Manchester, New Hampshire, United States

  • Study site

    Mays Landing, New Jersey, United States

  • Study site

    Morristown, New Jersey, United States

  • Study site

    Brooklyn, New York, United States

  • Study site

    Buffalo, New York, United States

  • Study site

    Lake Success, New York, United States

  • Study site

    Mineola, New York, United States

  • Study site

    New York, New York, United States

  • Study site

    Stony Brook, New York, United States

  • Study site

    Syracuse, New York, United States

  • Study site

    The Bronx, New York, United States

  • Study site

    Williamsville, New York, United States

  • Study site

    Chapel Hill, North Carolina, United States

  • Study site

    Durham, North Carolina, United States

  • Study site

    Oklahoma City, Oklahoma, United States

  • Study site

    Danville, Pennsylvania, United States

  • Study site

    Philadelphia, Pennsylvania, United States

  • Study site

    Greenville, South Carolina, United States

  • Study site

    Knoxville, Tennessee, United States

  • Study site

    Memphis, Tennessee, United States

  • Study site

    Dallas, Texas, United States

  • Study site

    Fort Worth, Texas, United States

  • Study site

    San Antonio, Texas, United States

  • Study site

    Burlington, Vermont, United States

  • Study site

    Charlottesville, Virginia, United States

  • Study site

    Fairfax, Virginia, United States

  • Study site

    Norfolk, Virginia, United States

  • Study site

    Seattle, Washington, United States

  • Study site

    Madison, Wisconsin, United States

  • Study site

    Milwaukee, Wisconsin, United States

  • Study site

    Edmonton, Alberta, Canada

  • Study site

    Halifax, Nova Scotia, Canada

  • Study site

    Burlington, Ontario, Canada

  • Study site

    Toronto, Ontario, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.